Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The study primary outcome is to demonstrate that the EUM100pro uterine contractions measurements is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC).
研究概览
简要总结
The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures uterine contractions based on the electrical activity of the uterine muscle.The study will compare the EUM100pro measurements to the already existing uterine contractions monitors (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of uterine contractions.
详细描述
The main objective of the study is to demonstrate that the EUM100pro is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC) in measuring uterine contractions. This will be performed by measuring the expectancy of time differences between the tocodynamometer/IUPC and the EUM in the beginning, end, peak and duration of each contraction. A good correlation will be 0.9 and significance of 95%.
100 women will be recruited to the study. The measurement with the EUM100pro will not interfere with the usual clinical care, meaning- the EUM100pro will be used in addition to the standard care and monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at term with complaint of uterine contractions at Meir Medical Center
- •Women at preterm with complaint of uterine contractions at Meir Medical Center.
- •Women at gestational age >24 weeks
- •Subjects who understood, agreed and signed the informed consent form
排除标准
- •Subjects who refused to sign the informed consent form
- •Abnormal fetal heart rate recording at admittance
- •Subjects with indications for immediate delivery
- •Subjects younger than 18 years of age
- •Subjects at gestational age <24 weeks
结局指标
主要结局
The study primary outcome is to demonstrate that the EUM100pro uterine contractions measurements is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC).
时间窗: two years
The primary outcome will be measured by correlation of timing of :peak display in beginning, during and end of peak in the EUM100pro versus the timing of the peak display in beginning, during and the end tocodynamometer and or IUPC peak.
To evaluate patient safety
时间窗: one year
Measurements of device related adverse events throughout the study.
次要结局
- Correlation of uterine contractions intensity between EUM100pro and Intra Uterine Pressure Catheter measurements.(one year)
- To evaluate usability of the EUM100pro(one year)
- to evaluate whether a fetal ECG can be exctraced from the electrical signal of the uterus.(one year)